| Methods |
DURATION OF INTERVENTION:
24 weeks +‐ 4 weeks
DURATION OF FOLLOW‐UP:
24 weeks
RUN‐IN PERIOD:
none
LANGUAGE OF PUBLICATION:
English |
| Participants |
WHO PARTCIPATED:
patients with type 2 diabetes mellitus
INCLUSION CRITERIA:
type 2 diabetes, treated with oral antidiabetic agents, but never received TZDs; age 40‐75 years; HbA1c >=6.6% and <=9.9%
EXCLUSION CRITERIA:
significant hepatic or renal disease; congestive heart failure (NYHA class II to IV), smoking at time of randomisation and during previous 6 months; carotid artery stenosis
DIAGNOSTIC CRITERIA:
not stated
CO‐MORBIDITIES:
not stated
CO‐MEDICATIONS:
‐ intervention: statins 20.2% at start, 32.8% at end; renin‐angiotensin inhibiting substances 58.4% at start, 60.7% at end; antiplatelet therapy 28.1% at start, 39.3% at end;
‐ control: statins 15.5% at start, 15.5% at end; renin‐angiotensin inhibiting substances 48.8% at start, 51.2% at end; antiplatelet therapy 31.0% at start, 40.5% at end;
‐ other additional antidiabetic medication, including SU but not metformin was allowed in the pioglitazone group; in the glimepiride group all kinds of other antidiabetic medication except TZDs were allowed. |
| Interventions |
NUMBER OF STUDY CENTRES:
one
COUNTRY/ LOCATION:
Germany
SETTING:
unclear
INTERVENTION (DOSE/DAY):
pioglitazone 45 mg/day
CONTROL (DOSE/DAY):
glimepiride 1 to 6 mg/day,
average dose 2.7+‐1.6 mg
TREATMENT BEFORE STUDY:
‐ intervention: 65.2% monotherapy, 34.8% combination therapy;
‐control: 63.1% monotherapy, 36.9% combination therapy.
TITRATION:
glimepiride titrated from 1 mg to 6 mg/day for optimal glycaemic control; duration of titration period not stated |
| Outcomes |
PRIMARY OUTCOMES:
not stated (carotid intima media thickness)
SECONDARY OUTCOMES:
HbA1c, fasting serum glucose, fasting serum insulin, HOMA: insulin resistance, BMI, blood pressure, lipid parameters, highly‐sensitive C‐reactive protein; von Willebrand factor |
| Notes |
AIM OF STUDY:
to investigate whether pioglitazone therapy decreases carotid intima media thickness in patients with type 2 diabetes (glimepirid‐based comparison group used to compensate for concomitant effects of metabolic control) |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
